Reported Apr 26, 2023 · Ongoing

Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip…

Olympus Corporation of the Americas

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229

Is this the product you have?

  • Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable, 165cm long, 2.8 scope channel, standard clip Model HX 201UR 135 - Rotatable, 230 cm long, 2.8 scope channel, standard clip Model HX 201UR 135L - Rotatable, 230 cm long, 2.8 mm scope channel, Long clip
Lot codes and dates
    • 1) UDI-DI 14953170353106
    • Model HX-201LR-135
    • Lot 1ZV 2) UDI-DI 14953170353113
    • Model HX-201UR-135
    • Lot 23V 3) UDI-DI 14953170353120
    • Model HX-201UR-135
    • Lot 24V 4) UDI-DI 14953170353168
    • Model HX-201UR-135L
    • Lot 24V
Amount recalled
65.9 boxes (373 pieces)

Where it was sold

  • Nationwide

Why it was recalled

There have been complaints that the clip did not come out of the tube sheath during the procedure.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:20 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.